Fresh from a Pfizer buyout, Luca Santarelli’s crew has created a new company — banking new funds and steering their lead drug to a pivotal

Luca Santarelli. Therachon

January 7, 2020 05:58 AM ESTUpdated April 23, 08:02 PM

Fresh from a Pfizer buyout, Luca Santarelli’s crew has created a new company — banking new funds and steering their lead drug to a pivotal

John Carroll

Editor & Founder

Almost exactly 3 years since he joined the biotech startup world as head of Therachon, the high-profile discovery scientist Luca Santarelli is ready to start 2020 with a new company, opening a new chapter with $35 million in financing from some close venture groups and plans that point straight to Phase III later this year while they hunt new development deals.

We knew last spring that Santarelli’s Basel-based biotech was being bought out by Pfizer for up to $810 million. The pharma giant wanted their drug for dwarfism, plucking it out but letting the 20-member team remain in charge of a separate rare disease drug for short bowel syndrome.

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Inside FDA HQ (File photo)

August 12, 2020 06:30 PM EDTUpdated 16 hours ago

Pharma

Regulatory

The FDA just approved the third Duchenne MD drug. And regulators still don’t know if any of them work

Max Gelman

Associate Editor

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Charlie Silver (Mission Bio)

August 14, 2020 07:03 AM EDT

Venture

Startups

'We want to be everywhere.' Mission Bio raises $70M behind resistance-hunting sequencing platform

Jason Mast

Associate Editor

Charlie Silver wants to look really, really closely at a lot of your cells. And he just got a lot of money to do so.

Silver’s startup, Mission Bio, raised $70 million in a Series C round Thursday led by Novo Holdings. The money, which brings Mission Bio to $120 million raised since its 2012 founding, will be used to advance the single-cell sequencing platform they built to detect early response or resistance to new cancer therapies.

Cell and Gene Contract Manufacturers Must Embrace Digitization

Rachit Jain

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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Franz-Werner Haas, CureVac CEO

August 14, 2020 06:32 AM EDTUpdated 07:44 AM

IPOs

3 weeks, 3 big investments capped by a $213M IPO bring CureVac’s instant-cash raise to a cool billion dollars

John Carroll

Editor & Founder

CureVac jumped onto Nasdaq Thursday night, landing with an extra $213 million after selling a batch of shares at $16 a pop. Add in an extra $118 million share purchase by founder Dietmar Hopp — who owns a controlling interest — and another $640 million from deals and the German biotech has raised a cool billion dollars in the space of just 3 weeks.

The company’s stock $CVAC will now start trading this morning, with analysts eager to find out whether the go-go atmosphere on Wall Street will swell the biotech’s share price.

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Martin Shkreli (Shutterstock)

August 14, 2020 07:28 AM EDT

People

Pharma

Martin Shkreli continued to orchestrate anti-competitive schemes for Daraprim behind bars — FTC

Amber Tong

Editor

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

NIH director Francis Collins at a Senate Appropriations subcommittee hearing for Operation Warp Speed (Graeme Jennings/Pool via AP Images)

August 14, 2020 07:18 AM EDT

Coronavirus

Covid-19 roundup: 'November or December' Collins' best bet on a vaccine OK; First plasma trial suggests mortality reduction

Amber Tong

Editor

Max Gelman

Associate Editor

Nicole DeFeudis

Associate Editor

Count NIH director Francis Collins out for any wager that the FDA would authorize a Covid-19 vaccine in October.

The discussion came up during a call with reporters because some states and local governments have been told by the CDC to have vaccination plans ready to go by Oct. 1. Pharma execs, most notably from Pfizer and BioNTech, have raised hopes about a licensure during that month; President Donald Trump last week sounded an optimistic note about having a vaccine on the market “right around” Election Day on Nov. 3 — or possibly before.

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August 13, 2020 10:49 AM EDT

Deals

R&D

Calliditas bets up to $102M on a biotech buyout, snagging a once-failed PBC drug

Nicole DeFeudis

Associate Editor

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to €55 million in contingent rights.

ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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August 13, 2020 10:20 AM EDTUpdated 10:44 AM

Deals

Qiagen investors spurn Thermo Fisher’s takeover offer, derailing a $12B+ deal

Max Gelman

Associate Editor

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

August 13, 2020 09:46 AM EDT

IPOs

China

CanSino reaps $748M windfall from Shanghai IPO — as it warns Covid-19 vaccine won't be a huge money maker

Amber Tong

Editor

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.